Senior Clinical Research Associate
1개월전에
Location: Seoul, Korea #LI-Hybrid
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
About the Role:
This role is assigned to more sophisticated trials and or to less experienced sites where applicable. This person takes on the responsibility to participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines and participates in multi-disciplinary teams locally and globally to evaluate and implement process improvements.
We are looking for Clinical Research Associate or Senior Clinical Research Associate. You may refer for more details at the essential requirements column.
Key Responsibilities:
• Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on achievement and results with true ownership attitude. Handles assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
• Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Re-trains site personnel as appropriate
• Conducts continuous site monitoring activities (onsite and remote). Implements' site management activities to ensure compliance with protocol, ICH/GCP, global and local regulation including Health Authorities, IRB/EC, data privacy requirements, global and local processes as applicable. Documentation according to GDP and Novartis standards.
• Identifies deficiencies in site processes and supervise site processes performed outside the site, works in close collaboration with site on risks mitigation and process improvements
• Promotes a compliance culture advocating adherence to the highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times
• Establish a positive relationship and true collaboration with the site, to increase patient density and decrease issues at site. Early engagement with site on patient inventory and patient flow in advance of SIV in close collaboration with global and local study team
• Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow-up activity and archiving requirements. Attends onboarding-, disease indication and project specific training and general CRA training as required
• Proactively collaborates with the relevant teams to ensure efficient recruitment, site development and data quality.
• Ensures that relevant site insights are shared with internal partners such as site partnership manager, medical advisor, MSL and CRMA etc. to improve one Novartis approach to sites. Participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines.
• Collaborates with internal partners and site personnel to handle data query resolution process and to ensure timely and accurate data entry. Responsible for collecting crucial documents from site and accountable to keep sTMF(s) up to date.
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